法莫替丁单室单层渗透泵片的制备

目的:以法莫替丁(famotidine,FMT)为模型药物研究难溶性药物单层渗透泵片的制备。方法:以PEO,HPMC,NaCl和柠檬酸组成片芯,以醋酸纤维素为包衣材料制备FMT单层渗透泵片,并对片芯组成优化;用相似因子法考察了体外释放条件。结果:片芯最佳组成为:FMT40 mg,PEON1065 mg,HPMCK4M70 mg,NaCl 50 mg,柠檬酸20 mg。释放介质和转速对药物释放无显著影响。本渗透泵片24 h恒速释药,累积释药率93%。结论:本渗透泵片制备简便,能较好地控制FMT24 h匀速释药。

Preparation of monolithic osmotic pump tablets of famotidine

Objective: To develop the monolithic osmotic pump tablets of famotidine.Methods:The monolithic osmotic pump tablets of famotidine were optimized and prepared using polyethylene oxide(PEO),hydroxypropyl methylcellulose(HPMC),NaCl and citrate acid as core materials followed by membrane coating using cellulose acetate.The release conditions in vitro were investigated by a similarity factor method.Results:The optimal core formulation was consisted of 40 mg famotidine,65 mg PEON10,70 mg HPMCK4M,50 mg NaCl and 20 mg citrate acid.The release media and stirring rate did not affect release rate of the drug.Famotidine was released as a zero-order process from the monolithic osmotic pump tablets for 24 h,and the cumulative release rate was 93%.Conclusions:A simple preparation method of the monolithic osmotic pump tablets of famotidine was developed,and the release rate of the drug met a zero-order process for 24 h.